Quote:There are issues with the BLA alright, and we don't know exactly what they are as what we know now is that there is a lot of data to be processed.
TG, I tend to believe that the "issues" with the BLA stem from the fact that CYDY initially ran the combo trial at 350 mg (apparently no dose escalation study done in P1) rather than the more effective 700 mg dose.
Now, whether due to FDA's insistence or CYDY's request (I tend to believe it's a combination regardless of what CYDY management has said), CYDY is attempting to file a BLA in combo therapy at 700 mg.
The FDA is a bureaucracy, and I wouldn't be shocked if this issue is breaking a few brains over there ("this is not protocol. how do we handle this? it's not in the manual ..."
. However, I do believe that the FDA is trying to work WITH CYDY to allow the BLA to go forward without CYDY having to run a new 700 mg trial (NP has stated this before). Sorry for the long post. In short, yes, I think there are "issues", but I think it stems mostly from the FDA figuring out what it needs to see from CYDY to make an exception for them (i.e., 350 vs. 700) and CYDY being extra cautious to dot all i's and cross all t's to avoid a CRL.
Just my two cents! I'm in your camp that I expect the BLA to be finalized Q1-ish.
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